The health care sector is becoming increasingly demanding. The ultimate end user drug consumer that is patient is the focal point/hub in the healthcare system. At the same time related entities such as doctors, pharmacies, insurance agency, pharmaceutical company, distributor etc. form important links/stakeholders and are integral part of the healthcare circle and their cognitive effort plays vital role in maintaining patients healthcare and providing value added services to him/her. Conventionally, these links are isolated and not integrated with the patient to understand his/her usage pattern of drug and related feedback. Further patient compliance and feedback plays a significant role in clinical research/trials as they provide insight by way of pharmacovigilance into the drug/medicine under development.
If these entities appropriately and authentically liaison with patient and work in tandem with the information generated by and from the patients end using means to link the patient and his/her compliance process such as his compliance with drug schedule, feedback about symptoms etc., synergistic effect could be produced resulting in patient compliance thereby enhancing quality of health care and providing value addition to all the links in this healthcare system. Various healthcare management systems are reported in the literature. They are as follows:
U.S. Pat. No. 6,961,285 discloses a system and process for assisting patients in taking medication and assisting third parties in accumulating information regarding patient medication intake. The instrumented medication package along with a portable medication package is communicably connected to the third parties via computer network. However, the process is restricted to only accumulating and transmitting data related to patient medication intake. However the system is not capable of integrated value added functionalities of product authentication, patient feedback, pharmacovigilance, etc.
U.S. Pat. No. 5,781,442 discloses patient management system capable of monitoring, controlling and tracking the administration of care in a health care institution. The invention provides a modular management system that processes the functional information from the hospital and its administration such as patient list and their data, ongoing procedures. This system is restricted to management of health care within an institution/hospital. Further the management system does not facilitate product authentication, online feedback of the patients with doctor, pharmacies, insurance agency, pharmaceutical company etc.
U.S. Pat. No. 6,021,392 discloses a system and method for drug and health care supply distribution and replenishment wherein a Health care provider/hospital having a, drug dispensing machine/hand held drug dispensing unit and second computer located at a drug supplier facility are in electronic communication with each other providing records of drugs received by the health care provider, drugs dispensed to patients at the health care provider, and an ongoing inventory of drugs stored at the health care provider. This inventory system is not capable of authenticating the drugs, or online record patient feedback, or network with value added services to doctors, pharmacies, insurance agency, pharmaceutical company etc at it is merely manages the drug inventory control.
The U.S. Pat. No. 5,390,238 discloses health care support method and system for health care support. The system comprises of health support unit for monitoring and supporting a patient monitoring terminal, and a network server coupled between the health support unit and monitoring terminal for exchanging information between health support units and monitoring terminal. The method comprises the steps of:                inputting a medication delivery schedule to the health support unit,        synthesizing speech in the health support unit to inquire a wellness status of the patient at predetermined intervals and to remind the patient to take medication as scheduled,        recognizing patient speech in the health support unit,        recording patient data concerning the patient's compliance with the medication delivery schedule and the patient's wellness check results,        transmitting patient data to a central network server for access by the patient's health care provider.        
However the system and the method disclosed is limited to monitoring the patients compliance with medication delivery schedule. Further it does not provide facility and method of liaison/interaction with the other entities in the health care circle such as doctors, pharmacies, insurance agency, pharmaceutical company, distributor etc.
U.S. Pat. No. 5,558,638 discloses a system for monitoring the health and medical requirements of plurality of patents at remote sites and providing these requirements to a care center. The system comprises a sensor for monitoring the patient's medical state, the sensor generating a parameter indicative of the patient's medical state; a data base located at a remote location from the sensor for storing the patient's medical state; a means for communicating the parameter to the data base; a means for retrieving the parameter from the data base; and a means for providing medical procedure to the patient in response to the retrieved parameter. It may be noted that this system allows for the collection of information from the patient through sensors on the patients and does not procure personal feedback from the patient nor does the system authenticate the drug being taken by the patient. Further this is not a system capable of. comprehensively managing a distributed healthcare system by integrating several of all the stake holders of a healthcare system.
U.S. Pat. No. 7,251,609 discloses a method for conducting clinical trials over the internet. The invention encompasses a method of conducting a clinical trial of a test substance from a primary site, via the internet The internet is used in various phases of a clinical trial, including: recruiting and screening for candidates who are eligible to participate in a clinical trial of a test substance using the internet; obtaining, directly from a participant at a remote site, personal information as well as information allowing a determination of any effect(s) of the test substance on the participant after use (e.g., by evaluation forms completed and transmitted over the internet); compiling data from multiple participants. This system does not procure personal feedback from the patient when he has consumed the medicine nor does the system authenticate the pack with the protocol being taken by the patient during a clinical trial. Further this is not a system capable of comprehensively managing a distributed healthcare system by integrating several of all the stakeholders of a healthcare system.
U.S. Pat. No. 5,778,882 discloses a health monitoring system which tracks the state of health of a patient and compiles a chronological health history of the patient uses a multiparametric monitor which periodically and automatically measures and records a plurality of physiological data from sensors in contact with the patients body. The data provides the information necessary to derive patterns, which are characteristic of healthy patients as well as those who are ill. The data collected is periodically uploaded to a database in which it is stored along with similar health histories for other patients. The, monitor is preferably self-contained in a chest strap, which is located on the patients torso, and makes use of a controller, which controls sampling of the desired data and storage of the data to a local memory device pending uploading to the database. Such a system allows for the collection, storage and retrieval of information from the patient via a chest strap on the patients. It does not procure online personal feedback from the patient nor does the system authenticate the pack with the protocol being taken by the patient in a normal course of treatment of during a clinical trial. Further this is not a system capable of comprehensively managing a distributed healthcare system by integrating several of all the stakeholders of a healthcare system.
U.S. Pat. No. 6,440,069 discloses Health monitoring system that monitors the health of a patient includes an ingestible capsule containing a medication to be consumed by a subject. A signal generator located within the capsule outputs an electrical signal having a predetermined characteristic indicative of said medication, said capsule and said medication being liberated by dissolution of the capsule in the stomach acid of a subject. A signal detector, preferably having an input in electrical contact with a portion of the subject's skin, is used to detect the electrical signal. This allows the ingestion of the medication to be tracked. As in the case of other prior art, it does not procure personal feedback from the patient nor does the system authenticate the pack with the protocol being taken by the patient in a normal course of treatment of during a clinical trial. Further this is not a system capable of comprehensively managing a distributed healthcare system by integrating several of all the stakeholders of a healthcare system.
Thus review of the prior art reveals following drawbacks:                The systems and methods do not address patient centric, interactive, authenticated integration of the complete cross section right from the medication package, insurance agency to pharmacists of the health care system wherein the interaction between them brings value to each of the entities and produces synergistic effect to ensure patient compliance including appropriate patient feedback from clinical trials and/or collection of pharmacovigilance data and in the process enhancing the value of the total healthcare system.        Methods and systems restricted to hospitals/health care institutions only        The information generated by the patient at his/her end, regarding drug consumption, its symptoms etc. is not been accessed/used/transmitted as a primary source to various links of the health care system.        The methods and systems do not provide the facility for patient registration and identification with the system, authentication & registration of the medication package and authentication of the facilitators such as medical practitioners, pharmacist etc. are not reported in the prior art        
There is a need to develop a personalized integrated healthcare anticounterfeit management method and a system thereof wherein patient is at the focal point (patient centric method) and stakeholders/healthcare agencies such as medical practitioners, health insurance agency, healthcare regulators, pharmaceutical companies, clinical researchers, pharmacies and medication package are integrated with the patient and also are in interaction/communication/liaison with each other via authenticated and registered process to provide the technical effect of user compliance to doctors prescription, recording user compliance to medication and acquiring patient feedback on the effects of the medication, maintaining data and displaying compliance and feedback information, liaising with users' nominated persons and medical practitioner, providing real-time and authentic data to insurance agencies, creating statistical and other reports which can be accessed by the healthcare agencies by means including websites/ftp sites. The present invention is also especially useful in clinical trials/research and pharmacovigilance in providing an effective and reliable way of monitoring patient compliance with a specified healthcare regime.